NCT01410747已完成不适用
Specified Drug Use-Results Survey on Long-Term Treatment for Prograf® Capsules 0.5 mg, 1 mg Lupus Nephritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,484
- 主要终点
- Incidence of renal events (renal failure and progression to dialysis)
研究概览
简要总结
To evaluate the safety and efficacy of tacrolimus for lupus nephritis under actual-use.
详细描述
The objectives of the survey are to evaluate the safety and efficacy of tacrolimus for lupus nephritis under actual-use situations, and to identify factors that might affect the safety and efficacy of tacrolimus. In addition, long-term renal outcome will be evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
tacrolimus group
Oral
干预措施: Tacrolimus (Drug)
结局指标
主要结局
Incidence of renal events (renal failure and progression to dialysis)
时间窗: Up to 10 years
次要结局
- 24-hour urinary protein(Baseline, 4 week, 8 week, 12 week, 1 year, 2 year, 3 year, 4 year, 5 year, 6 year, 7 year, 8 year, 9 year, 10 year)
- Urinary red blood cell (RBC) count(Baseline, 4 week, 8 week, 12 week, 1 year, 2 year, 3 year, 4 year, 5 year, 6 year, 7 year, 8 year, 9 year, 10 year)
- Serum creatinine(Baseline, 4 week, 8 week, 12 week, 1 year, 2 year, 3 year, 4 year, 5 year, 6 year, 7 year, 8 year, 9 year, 10 year)
研究者
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